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Lessons in Clinical Trial Design From the Traumatic Coma Data Bank

  • L. F. Marshall
  • S. Bowers Marshall
Conference paper

Abstract

In 1979, the San Diego experience with hypnotics was presented for the first time at a meeting in Charlottesville, Virginia. At that time, Professor Bryan Jennett presented a slide which made the following suggestions for the comparisons of new treatments with present methods of care. Suggestions and questions were:
  1. 1.

    Are the patients well matched?

     
  2. 2.

    Are the treatments well controlled?

     
  3. 3.

    Had the outcome measures been selected in advance, and are they clear?

     

Keywords

Head Injury Cerebral Perfusion Pressure Glasgow Outcome Scale Severe Head Injury Diffuse Injury 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Chesnut RM, Marshall LF, Klauber MR, Blunt BA, Baldwin N, Eisenberg HM, Jane JA, Marmarou A, Foulkes MA. The role of secondary brain injury in determining outcome from severe head injury: Analysis of the frequency of occurrence and impact on outcome of hypotension and hypoxia and their interactions with severe multiple trauma in severely brain injured patients. Submitted to JAMAGoogle Scholar
  2. 2.
    Eisenberg HM, Cayard C, Papanicolaou A, Weiner R, Franklin D, Jane J, Grossman R, Tabaddor K, Becker DP, Marshall LF, Kunitz S (1983) The effects of three potentially preventable complications on outcome after severe closed head injury. In: Ishii S, Nagai H, Brock M (eds) Intracranial pressure V. Springer, Berlin Heidelberg New York Tokyo, pp 549–553CrossRefGoogle Scholar
  3. 3.
    Eisenberg HM, Gary HE Jr, Turner B, Jane JA, Marmarou A, Marshall LF, Young HF, and the NIH TCDB Writing Group (1989) CT scan finding in 683 patients with severe (GCS ≤ 8) closed head injury: A report from the NIH Traumatic Coma Data Bank. In: Hoff JT, Betz AL (eds) Intracranial pressure VII. Springer, Berlin Heidelberg New York London Paris Tokyo Hong Kong, pp 557–559Google Scholar
  4. 4.
    Luerssen TG, Hults KR, Klauber Mr, et al. (1989) Improved outcome as a result of recognition of absent or compressed cisterns on admitting CT scan. In: Hoff JT, Betz AL (eds) Intracranial pressure VII. Springer, Berlin Heidelberg New York London Paris Tokyo Hong Kong, pp 598–602Google Scholar
  5. 5.
    Marmarou A, Anderson RL, Ward JD, Choi SC, Young HF, Eisenberg HM, Foulkes MA, Marshall LF, Jane JA: Impact of ICP instability and hypotension on outcome in patients with severe head trauma. J Neurosurg (submitted)Google Scholar
  6. 6.
    Teasdale E, Cardoso E, Galbraith S, et al. (1984) CT scan in severe diffuse head injury: physiological and clinical correlations. J Neurol, Neurosurg and Psychiatry 47:600–603CrossRefGoogle Scholar
  7. 7.
    Toutant SM, Klauber MR, Marshall LF, et al. (1984) Absent or compressed basal cisterns on first CT scan: Ominous predictors of outcome in severe head injury. Neurosurg 61:691–694CrossRefGoogle Scholar
  8. 8.
    van Dongen KJ, Braakman R, Gelpke GJ (1983) The prognostic value of computerized tomography in comatose head-injured patients. J Neurosurg 59:951–957PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1993

Authors and Affiliations

  • L. F. Marshall
    • 1
  • S. Bowers Marshall
    • 1
  1. 1.Division of Neurological SurgeryUniversity of California Medical CentreSan DiegoUSA

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